(60 days)
The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that:
- precludes satisfactory spectacle lens correction
- demonstrates significant improved rigid contact lens corrected vision
- is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.
The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
- · oprifocon A (supplied by Bausch & Lomb, Inc.)
- · hexafocon B (supplied by Bausch & Lomb, Inc.)
The BostonSight PD Prosthetic Device is designed to vault over the cornea and rest on the conjunctiva overlying the sclera, resulting in a tear reservoir between the back surface of the prosthetic device and the corneal surface. The tear reservoir masks optical distortions from an irregular corneal surface, and in combination with the device itself, protects the ocular surface from an adverse external environment, including but not limited to dysfunctional evelids and margins. The design parameters are customized to allow for tear exchange underneath the device.
The BostonSight PD Prosthetic Device may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight PD Prosthetic Device is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685. When shipped "wet". The BostonSight PD Prosthetic Device manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight PD Prosthetic Device manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.
This document is a 510(k) Summary of Safety and Effectiveness for the BostonSight PD Prosthetic Device, a rigid gas permeable contact lens. As such, it does not contain a study or data proving the device meets acceptance criteria. Instead, it asserts substantial equivalence to predicate devices based on device characteristics, indications for use, and a reliance on prior clearances for materials and clinical performance of similar devices.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and statistical analyses cannot be extracted from this document. However, I can provide the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for performance. Instead, it relies on substantial equivalence to predicate devices, implying that if the new device is sufficiently similar to the legally marketed predicate devices, it is considered safe and effective. The table below summarizes the comparison to predicate devices, which implicitly defines the "performance" as being comparable in key design and material aspects.
| Characteristic | BostonSight PD Prosthetic Device (Subject Device) | BostonSight IC Corneal & Scleral Lens (K153066) (Predicate Device) | Boston® Scleral (itafluorofocon B) RGP Contact Lens (P860022/S40) (Predicate Device) |
|---|---|---|---|
| Indication for Use | Therapeutic use in eyes with ocular surface disease from dry eye, limbal stem cell deficiency, disorders of the skin, neurotrophic keratitis, and corneal exposure. May incidentally correct refractive error. | Correction of refractive error in aphakic and non-aphakic persons. For management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-keratoplasty or LASIK). | Significantly reduced vision due to distorted corneal surface: |
- precludes satisfactory spectacle lens correction
- demonstrates significantly improved RGP contact lens corrected vision
- incapable of wearing traditional corneal lenses
Also for ocular surface disorders benefiting from physical protection and saline bath. |
| Device Classification | Class II, Lenses, Rigid Gas Permeable, Daily Wear, HQD | Class II, Lenses, Rigid Gas Permeable, Daily Wear, HQD | Class II, Lenses, Rigid Gas Permeable, Daily Wear, HQD |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate |
| Water Content |
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.